Optimization of the Care Pathway for Patients With Chronic Pain: Assessing the Value of Integrating Sleep Specialists

Last updated: December 19, 2023
Sponsor: Centre Hospitalier Emile Roux
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chronic Pain

Pain

Treatment

Standard pain management combined with sleep disorder management

Clinical Study ID

NCT06052384
RIPH2_PEREZ_DOLOREPIT
2022-A00919-34
  • Ages > 18
  • All Genders

Study Summary

DOLOREPIT is an interventional, RIPH 2, multicenter, randomized, controlled, open-label study comparing two care pathways for the management of patients with chronic pain.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • First consultation at the pain management center
  • Patient with chronic pain as defined by the "Haute Autorité de Santé". The pain musthave several of the following characteristics:
  • Persistence or recurrence
  • Duration beyond what is usual for the presumed initial cause, especially if thepain has been evolving for more than 3 months;
  • Inadequate response to treatment;
  • Important and progressive deterioration of the patient's functional andinterpersonal abilities in activities of daily living at home, school, or workdue to the pain.
  • Patients with chronic primary pain (according to the typology defined by theInternational Classification of Diseases-11) and classified into one of the 4following categories:
  • Chronic generalized pain
  • Complex regional pain syndrome
  • Chronic primary headache or orofacial pain
  • Chronic primary musculoskeletal pain
  • Pittsburgh Sleep Quality Index (PSQI) must be completed by the patient and the scoremust be available (for randomization purposes)
  • Have access to an internet connection as a self-administered questionnaire is tocomplete online, and at least have access to the online platform for CBT treatment ifinsomnia is detected
  • Affiliation to a French social security system
  • Free informed consent

Exclusion

Exclusion Criteria:

  • Patients undergoing cancer treatment or who have completed treatment within the last 2years
  • Patient with a chronic inflammatory disease (e.g. rheumatoid arthritis, ankylosingspondylitis, chronic inflammatory bowel disease, Horton's disease, Wegener's disease,myositis, Still's disease, lupus erythematosus, etc.)
  • Immunocompromised patient
  • Patient with severe psychiatric pathology that does not allow study follow-up (at thediscretion of the investigator)
  • Patient already treated for a sleep disorder by a sleep specialist (the onlyprescription of hypnotics is not considered as a criterion of non-inclusion)
  • Patient follow-up difficult (for geographic motives or other reasons)
  • Patient under judicial protection of incapable adults or guardianship
  • Refusal to participate in the research

Study Design

Total Participants: 664
Treatment Group(s): 1
Primary Treatment: Standard pain management combined with sleep disorder management
Phase:
Study Start date:
December 07, 2023
Estimated Completion Date:
April 30, 2027

Connect with a study center

  • Centre Hospitalier Emile Roux

    Le Puy-en-Velay,
    France

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.